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Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO~2~VATE trials by Kai-Uwe Eckardt; Rajiv Agarwal; Youssef Mk Farag; Alan G Jardine; Zeeshan Khawaja; Mark J Koury; Wenli Luo; Kunihiro Matsushita; Peter A McCullough; Patrick Parfrey; Geoffrey Ross; Mark J Sarnak; Dennis Vargo; Wolfgang C Winkelmayer; Glenn M Chertow is a Medicine article available to read on EtoBox.

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## Abstract ## Background Erythropoiesis-stimulating agents (ESAs) are currently the mainstay of treatment for anaemia of chronic kidney disease (CKD). Vadadustat is an investigational oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates endogenous erythropoietin formation. The INNO~2~VATE programme comprises two studies designed to evaluate the safety and efficacy of vadadustat versus the ESA darbepoetin alfa in ameliorating anaemia in patients with dialysis-dependent CKD (DD-CKD). Here we describe the trial design along with patient demographics and baseline characteristics. ## Methods Two Phase 3, open-label, sponsor-blind, active-controlled trials enrolled adults with anaemia of CKD who recently initiated dialysis and had limited ESA exposure (incident DD-CKD trial) or were receiving maintenance dialysis with ESA treatment (prevalent DD-CKD trial). Study periods include correction/conversion (Weeks 0–23), maintenance (Weeks 24–52), long-term treatment (Weeks 53 to end of treatment) and safety follow-up. The primary safety endpoint is the time to the first major adverse cardiovascular event and the primary efficacy endpoint is the change in haemoglobin (bas

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Author

Kai-Uwe Eckardt; Rajiv Agarwal; Youssef Mk Farag; Alan G Jardine; Zeeshan Khawaja; Mark J Koury; Wenli Luo; Kunihiro Matsushita; Peter A McCullough; Patrick Parfrey; Geoffrey Ross; Mark J Sarnak; Dennis Vargo; Wolfgang C Winkelmayer; Glenn M Chertow

Publisher

Oxford University Press; Oxford University Press (OUP) (ISSN 0931-0509)

Published

2020

Language

EN

Field

Medicine (Health Sciences)